MSAT Technical Lead - Drug Substance - Biologics

📋 Description Subject matter expert for DS Biologics manufacturing. Process owner of DS Biologics validation for Sobi products. Lead MSAT projects for process and cost improvements in lifecycle management. Lead internal/external manufacturing activities: changes, deviations, CAPAs. Review and approve SOPs and manufacturing instructions. Oversee product transfer, scale-up and external manufacturing. 🎯 Requirements University degree in Biology, Biotechnology, Pharmacy or related. 10+ years DS Biologics manufacturing for commercial use. Strong Upstream Manufacturing: cell banking and new working cell bank. Scale-down models and qualification experience. Regulatory guidelines familiarity and authorities' communication. Fluent in English; travel up to 30%. 🎁 Benefits Emphasis on work/life balance Collaborative and team-oriented environment Opportunities for professional growth Diversity and Inclusion Competitive compensation Making a positive impact for ultra-rare disease patients